RECRUITING

SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care

Conditions

Child Behavior Problem Attention Deficit and Disruptive Behavior Disorders Oppositional Defiant Disorder Attention Deficit Hyperactivity Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.

Official Title

Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial

Quick Facts

Study Start:2021-11-29

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04946253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* PCP Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as a Primary Care Provider * CM Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager. * SL Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as the Senior Leader. * Have a practice-level leadership role such as Medical Director or a clinical/practice leader * Have administrative responsibilities related to patient care and/or the operations/management of the practice * PM Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as the Practice Manager or equivalent position * Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice. * Caregiver Participants: * Have a child age 5-12 years old who exhibits at least a modest level of behavior problems (Caregiver Participants) * Are at least 18 years of age (Caregiver participants) * Have parental rights for this child (Caregiver participants)	* Caregivers * Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)

Inclusion Criteria

Exclusion Criteria

* PCP Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as a Primary Care Provider
* CM Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager.
* SL Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as the Senior Leader.
* Have a practice-level leadership role such as Medical Director or a clinical/practice leader
* Have administrative responsibilities related to patient care and/or the operations/management of the practice
* PM Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as the Practice Manager or equivalent position
* Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice.
* Caregiver Participants:
* Have a child age 5-12 years old who exhibits at least a modest level of behavior problems (Caregiver Participants)
* Are at least 18 years of age (Caregiver participants)
* Have parental rights for this child (Caregiver participants)

* Caregivers
* Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)

Contacts and Locations

Study Contact

Kevin M Rumbarger, BA

CONTACT

4128867539

rumbargerkm@upmc.edu

Omar Nogueras, BA

CONTACT

4122665826

nogueraso@upmc.edu

Principal Investigator

David J Kolko, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Drexel University

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

David J Kolko, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-29

Study Completion Date2026-11

Study Record Updates

Study Start Date2021-11-29

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Oppositional Defiant Disorder
Attention Deficit Hyperactivity Disorder

Additional Relevant MeSH Terms

Child Behavior Problem
Attention Deficit and Disruptive Behavior Disorders